Elestrin

PATIENT INFORMATION

ELESTRIN™
(estradiol) Gel

Read this PATIENT INFORMATION before you start using
ELESTRIN and read what you get each time you refill your ELESTRIN prescription.
There may be new information. This information does not take the place of
talking to your healthcare provider about your menopausal symptoms or your
treatment.

What is the most important information I should know
about ELESTRIN (an estrogen hormone)?

Using estrogen-alone may increase your chance of getting
cancer of the uterus (womb)
Report any unusual vaginal bleeding right away while you are using ELESTRIN.
Vaginal bleeding after menopause may be a warning sign of cancer of the uterus
(womb). Your healthcare provider should check any unusual vaginal bleeding to
find out the cause.

Do not use estrogen-alone to prevent heart disease, heart
attacks, strokes, or dementia (decline in brain function)

Using estrogen-alone may increase your chances of getting
strokes or blood clots

Using estrogen-alone may increase your chance of getting
dementia, based on a study of women age 65 years or older

Do not use estrogens with progestins to prevent heart
disease, heart attacks, strokes or dementia

Using estrogens with progestins may increase your chance
of getting dementia, based on a study of women age 65 years or older

You and your healthcare provider should talk regularly
about whether you still need treatment with ELESTRIN

What is ELESTRIN?

ELESTRIN is a medicine in a colorless gel that contains
an estrogen hormone (estradiol) which is absorbed through the skin into the
bloodstream.

What is ELESTRIN used for?

ELESTRIN is used after menopause to:

Reduce moderate to severe hot flashes

Estrogens are hormones made by a woman's ovaries. The
ovaries normally stop making estrogens when a woman is between 45 to 55 years
old. This drop in body estrogen levels causes the “change of life” or
menopause (the end of monthly menstrual periods). Sometimes, both ovaries are
removed during an operation before natural menopause takes place. The sudden
drop in estrogen levels causes “surgical menopause.”

When the estrogen levels begin dropping, some women
develop very uncomfortable symptoms, such as feelings of warmth in the face,
neck, and chest, or sudden strong feelings of heat and sweating (“hot
flashes” or “hot flushes”). In some women, the symptoms are
mild, and they will not need estrogens. In other women, symptoms can be more
severe. You and your healthcare provider should talk regularly about whether
you still need treatment with ELESTRIN.

Who should not use ELESTRIN?

Do not start using ELESTRIN if you:

Have unusual vaginal bleeding

Currently have or have had certain cancers
Estrogens may increase the chance of getting certain
types of cancers, including cancer of the breast or uterus. If you have or have
had cancer, talk with your healthcare provider about whether you should use ELESTRIN.

Had a stroke or heart attack

Currently have or have had blood clots

Currently have or have had liver problems

Have been diagnosed with a bleeding disorder

Are allergic to ELESTRIN or any of its ingredients See the list of ingredients in ELESTRIN at the end of this leaflet

Think you may be pregnant

Tell your healthcare provider:

If you have any unusual vaginal bleeding Vaginal bleeding after menopause may be a warning sign of cancer of the
uterus (womb). Your healthcare provider should check any unusual vaginal
bleeding to find out the cause.

About all of your medical problems Your healthcare provider may need to check you more carefully if you have
certain conditions, such as asthma (wheezing), epilepsy (seizures), diabetes,
migraine, endometriosis, lupus, or problems with your heart, liver, thyroid,
kidneys, or have high calcium levels in your blood.

About all the medicines you take This includes prescription and nonprescription medicines, vitamins, and herbal
supplements. Some medicines may affect how ELESTRIN works. ELESTRIN may also
affect how your other medicines work.

If you are going to have surgery or will be on bed
rest You may need to stop using ELESTRIN.

If you are breastfeeding The hormone in ELESTRIN can pass into your breast milk.

How should I use ELESTRIN?

Start at the lowest dose and talk to your healthcare
provider about how well that dose is working for you.

ELESTRIN should be used at the lowest dose possible for
your treatment and only as long as needed. You and your healthcare provider
should talk regularly (for example, every 3 to 6 months) about the dose you are
taking and whether you still need treatment with ELESTRIN.

ELESTRIN comes in a metered-dose pump. One dose of ELESTRIN
is released each time the pump is depressed (pressed down).

Use ELESTRIN exactly how your healthcare provider tells
you.

The ELESTRIN pump contains enough of the medicine to let
you prime the pump (get the pump ready) before you use it the first time. To
prime the pump, push the head of the pump down slowly , then remove your finger
from the pump head and allow it to spring back automatically (by itself).
Repeat this until the gel comes out. Throw away this first amount of gel as it
will not be a full dose. Once the pump head has come all the way back up, the
pump is now primed and ready to use. With each dose, remember to push the pump
head down slowly and allow it to spring back automatically let the pump head
come all the way back up before you push it down again. If using more than 1
dose, wait 5 seconds before pumping the next dose. This will make sure that the
pump works correctly and gives your full dose of ELESTRIN. Use the pump a total
of 30 times (30 pushes) as your healthcare provider tells you. After you have
initially primed the pump and have used a total of 30 doses of ELESTRIN, you
will need to throw the pump away and use a new one. The correct amount of
medicine in each dose cannot be assured after 30 doses have been used, even though
the pump container is not completely empty.

Important things to remember when using ELESTRIN

Wash your hands with soap and water after applying the
gel to reduce the chance that the medicine will be spread from your hands to
other people.

Allow the gel to dry for five minutes or more before
dressing. Try to keep the area dry for as long as possible.

Do not allow others to come in contact with the area of
skin where you applied the gel for at least two hours after you apply ELESTRIN.
Always move the spout into locked position and place the cap over the top of
the pump after each use.

Never apply ELESTRIN to the breast. Never apply ELESTRIN
in or around the vagina.

Do not allow others to apply the gel for you.

Do not apply sunscreen to the area where the gel was
applied for at least 25 minutes.

Do not apply sunscreen to the area where the gel was
applied for 7 or more consecutive days.

Avoid fire, flame or smoking until the gel has dried.
ELESTRIN contains alcohol. Alcohol based gels are flammable.

It is important that you read and follow the detailed
“Patient Instructions for Use” at the end of this leaflet on how to
use the ELESTRIN pump and apply the dose.

What should I do if someone else is exposed to
ELESTRIN?

If someone else is exposed to ELESTRIN by direct contact
with the gel, that person should wash the area of contact with soap and water
as soon as possible. The longer the gel is in contact with the skin before
washing, the greater is the chance that the other person will absorb some of
the estrogen hormone. This is especially important for men and children.

What should I do if I get ELESTRIN in my eyes?

If you get ELESTRIN in your eyes, rinse your eyes right
away with warm clean water to flush out any ELESTRIN. Seek medical attention if
needed.

What should I do if I miss a dose?

If you miss a dose, do not double the dose on the next
day to catch up. If your next dose is less than 12 hours away, it is best just
to wait and apply your normal dose the next day. If it is more than 12 hours
until the next dose, apply the dose you missed and resume your normal dosing
the next day.

What are the possible side effects of ELESTRIN?

Side effects are grouped by how serious they are and how
often they happen when you are treated. Serious, but less common side effects
include:

These are not all the possible side effects of ELESTRIN.
For more information, ask your healthcare provider or pharmacist for advice
about side effects. You may report side effects to Meda Pharmaceuticals at
1-800-890-3098 or to FDA at 1-800-FDA-1088.

What can I do to lower my chances of a serious side
effect with ELESTRIN?

Talk with your healthcare provider regularly about
whether you should continue using ELESTRIN

If you have a uterus, talk to your healthcare provider
about whether the addition of a progestin is right for you
The addition of a
progestin is generally recommended for a woman with a uterus to reduce the
chance of getting cancer of the uterus. See your healthcare provider right away
if you get vaginal bleeding while using ELESTRIN.

Have a pelvic exam, breast exam and mammogram (breast X-ray)
every year unless your healthcare provider tells you something else If members
of your family have had breast cancer or if you have ever had breast lumps or
an abnormal mammogram, you may need to have breast exams more often.

If you have high blood pressure, high cholesterol (fat in
the blood), diabetes, are overweight, or if you use tobacco, you may have a
higher chance for getting heart disease
Ask your healthcare provider for ways to lower your
chances of getting heart disease.

General information about safe and effective use of
ELESTRIN

Medicines are sometimes prescribed for conditions that
are not mentioned in patient information leaflets. Do not use ELESTRIN for
conditions for which it was not prescribed. Do not give ELESTRIN to other people,
even if they have the same symptoms you have. It may harm them.

Keep ELESTRIN out of the reach of children

This leaflet provides a summary of the most important
information about ELESTRIN. If you would like more information, talk with your
healthcare provider or pharmacist. You can ask for information about ELESTRIN
that is written for health professionals. You can get more information by
calling 1-800-890-3098 (toll free).

Patient Instructions for Use.

1. Remove the cap.

2. Activate the pump.

Unlock the pump by turning the spout on top of the bottle
a quarter turn to the left or the right.

3. Prime the pump (get the pump ready) before using
the pump for the first time.

Push the head of the pump down slowly and allow it to
spring back automatically. Repeat this until gel comes out. Throw away the
first amount of gel as it will not be a full dose. Once the pump head has come
all the way back up, the pump is now primed and ready to use. Throw away the
unused gel by placing it in the trash to avoid another person or pet from
accidental contact with the gel or, eating or drinking it.

After priming, the pump is ready to use.

One complete pump depression will dispense the same
amount of ELESTRIN each time. After each daily dose, return the spout to the
locked position and replace the cap before you put it away.

4. Apply ELESTRIN.

Dry skin completely before applying ELESTRIN

You should apply your daily dose of gel to clean, dry,
unbroken skin. If you take a bath or shower or use a sauna, apply ELESTRIN
after your bath, shower, or sauna. If you go swimming, try to leave as much
time as possible, at least 2 hours, between applying your ELESTRIN dose and
going into the water.

Apply ELESTRIN at the same time each day.

Figure 1

To apply the dose, hold the pump with the tip facing the
application area of the arm. For each pump depression needed, press the pump
firmly and fully with a continuous motion without hesitation.

Figure 2

Gently spread the gel using only
2 fingers. Spread and gently rub in the gel over the entire area of your upper
arm and shoulder area, as illustrated.

5. Wash your hands with soap
and water.

ELESTRIN should not be used
after the date printed on the container (expiration date).